The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse Post-Market Surveillance Clinical Study

The purpose of this study is to assess the long-term safety, durability of clinical effectiveness and cost effectiveness of the NeuGuide device in the treatment of patients with uterine prolapse.

Uterine prolapse is a type of hernia in which the uterus has lost its structural support and falls or protrudes into the vagina or through the vaginal opening. The NeuGuide System for Vaginal Colpopexy is an FDA-approved device used to suspend and support the top of the vagina so that the prolapse of the uterus is prevented or reduced. This device is a minimally invasive surgical tool to facilitate the repositioning and support of the uterus. The purpose of this sudy is to gather additional information about the use and effect of the NeuGuide device.

Fairfax Medical Campus Women’s Hospital
3300 Gallows Rd.
Falls Church, Virginia 22042

• Patient is >35 and <85 years of age.
• Non-pregnant female (female of child bearing potential must have a negative pregnancy test).
• Patient understands the nature and potential hazards of the procedure and provides written informed consent prior to any study specific assessments.
• Patient is able to complete written questionnaires.
• Patient is willing and able to comply with the specified study requirements and follow-up assessments and can be contacted by telephone.

• Known diagnosis of reproductive tract abnormalities.
• Prior pelvic radiation therapy, or active pelvic inflammatory disease.
• Known history of severe Pelvic Inflammatory Disease (PID).
• Prior total hysterectomy.
• Severe morbid obesity (BMI >45).
• Planned surgery (more than a minor one) in the next 30 days.
• Known hypersensitivity to device materials (Nickel, suture material).